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Lecanemab for Early Onset Familial Alzheimer's Disease | Clinical Trials | Clareo Health

RECRUITING

Lecanemab for Early Onset Familial Alzheimer's Disease

A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease

NCT06883019•RenJi Hospital

Summary

The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing. The study will explore the effects of genetic and hereditary factors on the efficacy of Lecanemab treatment in early-onset familial AD patients.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age at onset ≤ 65 years, with a minimum age of 18 years; no restriction on gender.
•Diagnosis of Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI): Must meet the clinical diagnostic criteria for AD-related MCI and mild AD as defined by the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011); confirmed Aβ positivity through Aβ-PET/CT, Aβ-PET/MRI, or cerebrospinal fluid testing.
•MMSE ≥ 21 or MoCA ≥ 17 or CDR = 0.5
•No significant signs found in the neurological examination
•Participants must be capable of completing cognitive assessments and other tests.
•Informed consent must be obtained from the participants and their legal guardians, with a dated signature, prior to any operations or tests related to the protocol, committing to comply with the research procedures and cooperate throughout the study process.

Exclusion Criteria

•Cognitive decline caused by other reasons: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (drugs, alcohol, CO, etc.), significant systemic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural hematoma, brain tumor), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiencies or any other reasons.
•Patients with other unstable diseases, or those who have had a stroke or transient ischemic attack, bleeding disorders, or seizures within the previous 12 months.
•Patients with psychiatric disorders who meet DSM-IV criteria for schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium.
•Patients with unstable or severe heart, lung, liver, kidney, hematological diseases; those with known malignancies or other serious prognoses.
•Exclusion of cerebral amyloid angiopathy-related inflammation/β-amyloid-related cerebral vasculitis (CAAri/ABRA).
•Presence of uncorrectable visual or auditory impairments that prevent completion of relevant assessments or scales.
•Patients who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants.
•MRI findings showing more than four microhemorrhages (diameter \< 10 mm), evidence of surface iron deposition, vascular edema, diffuse white matter disease, multiple lacunar strokes, or any strokes involving major vascular regions. Presence of evidence of cerebral contusions, brain softening, cerebral aneurysms, or other vascular malformations, central nervous system (CNS) infections, as well as brain tumors other than meningiomas or arachnoid cysts.
•Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders.
•Pregnant or lactating women.
+1 more criteria

Locations (15)

Xuanwu Hospital, Capital Medical University

Beijing, China, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangdong, China, China

The Affiliated Hospital of Guizhou Medical University

Guizhou, China, China

Nanjing Brain Hospital

Jiangsu, China, China

Nanjing Drum Tower Hospital

Jiangsu, China, China

Nantong First People's Hospital

Jiangsu, China, China

Huadong Hospital, Fudan University

Shanghai, China, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China

Shanghai Mental Health Center

Shanghai, China, China

Key Dates

Start Date

March 13, 2025

Primary Completion Date

June 30, 2027

Completion Date

August 31, 2027

Last Updated

March 19, 2025

Enrollment

114

ESTIMATED participants

Conditions

Alzheimer Disease

Contacts

Jinwen Xiao

CONTACT

+86 13917310784 jw_xiao78@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lecanemab for Early Onset Familial Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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